Perampanel (2) – Fycompa®

• Clinical trials
  • The pharmaceutical manufacturer’s pool of studies designed to demonstrate the additional benefit of perampanel comprises three randomised controlled trials (RCTs; E2007-G000-304, E2007-G000-305 and E2007-G000-306). These studies are randomised, double-blind, placebo-controlled trials with a parallel-group design and a treatment phase of 19 weeks.

Adjunctive therapy for focal seizures with or without secondary generalisation in patients with epilepsy aged 12 years and over

• For the adjunctive treatment of focal seizures with or without secondary generalisation in epilepsy patients aged 12 years and over, the additional benefit of perampanel compared with the appropriate comparator therapy is not proven.
• The studies submitted by the pharmaceutical manufacturer are not suitable for assessing the additional benefit of perampanel compared with the G-BA’s appropriate comparator therapy. This is because the G-BA’s appropriate comparator therapy was not implemented in the studies.
• In all three studies (E2007-G000-304, E2007-G000-305 and E2007-G000-306), the appropriate comparator therapy specified by the G-BA was not implemented; they are therefore not suitable for assessing the additional benefit compared with the G-BA’s appropriate comparator therapy.

Courtesy translation only, please refer to the German original.